eCite Digital Repository

Study on the classification, causality, preventability and severity of adverse drug reaction using spontaneous reporting system in hospitalized patients

Citation

Sundaran, S and Udayan, A and Hareendranath, K and Eliyas, B and Ganesan, B and Hassan, A and Subash, R and Palakkal, V and Salahudeen, MS, Study on the classification, causality, preventability and severity of adverse drug reaction using spontaneous reporting system in hospitalized patients, Pharmacy, 6, (4) Article 108. ISSN 2226-4787 (2018) [Refereed Article]


Preview
PDF
233Kb
  

Copyright Statement

Copyright 2018 The Authors Licensed under Creative Commons Attribution 4.0 International (CC BY 4.0) https://creativecommons.org/licenses/by/4.0/

DOI: doi:10.3390/pharmacy6040108

Abstract

Hospital-based adverse drug reaction (ADR) monitoring and reporting programs intend to identify and quantify the risks associated with the use of medicines. To examine the causality, preventability and severity of ADR in a hospital setting; a prospective cohort study on spontaneous ADR reporting was conducted from December 2015 to May 2016. Incidence of ADRs, causality, type, severity and preventability were assessed using necessary assessment scales. The study included 3157 hospitalized individuals, in whom 51 ADRs were detected among 49 patients. The overall incidence of suspected ADRs was found to be 1.6%. According to the causality assessment, most of the ADRs reported were probable (n = 26, 51.0%), and type A (augmented/pharmacological) reactions (n = 39, 76%) were the most common type of ADR found. The majority of ADRs were moderate to severe (n = 35, 68.6%), of which 37.3% were found to be potentially preventable. Predictability was observed in 28 (54.9%) reported ADRs. The prescribed medicines most frequently associated with ADRs were antibiotics, antiepileptics and antihypertensives. This feasibility study was able to highlight the clinical pharmacist’s role in ADR monitoring service and create awareness about the way it could be done to promote safer medication use. Similar ADR reporting programs are necessary to educate and to improve awareness among healthcare professionals in some countries.

Item Details

Item Type:Refereed Article
Keywords:adverse drug reactions, spontaneous reporting, causality, ADR, severity
Research Division:Medical and Health Sciences
Research Group:Pharmacology and Pharmaceutical Sciences
Research Field:Clinical Pharmacy and Pharmacy Practice
Objective Division:Health
Objective Group:Public Health (excl. Specific Population Health)
Objective Field:Health Status (e.g. Indicators of Well-Being)
UTAS Author:Salahudeen, MS (Dr Mohammed Salahudeen)
ID Code:129178
Year Published:2018
Web of Science® Times Cited:2
Deposited By:Pharmacy
Deposited On:2018-11-13
Last Modified:2019-02-22
Downloads:17 View Download Statistics

Repository Staff Only: item control page